The present invention relates to instruments to conduct minimally invasive medical procedures with the aid of laparoscopic techniques, and to such procedures themselves. More particularly, the present invention relates to high-intensity focused ultrasound ablation of tissue using minimally invasive medical procedures.
Several minimally invasive and non-invasive techniques for the treatment of living tissues and organs with ultrasound, including high-intensity, focused ultrasound, sometimes referred to hereinafter as HIFU, are known. There are, for example, the techniques and apparatus described in U.S. Pat. Nos. 4,084,582; 4,207,901; 4,223,560; 4,227,417; 4,248,090; 4,257,271; 4,317,370; 4,325,381; 4,586,512; 4,620,546; 4,658,828; 4,664,121; 4,858,613; 4,951,653; 4,955,365; 5,036,855; 5,054,470; 5,080,102; 5,117,832; 5,149,319; 5,215,680; 5,219,401; 5,247,935; 5,295,484; 5,316,000; 5,391,197; 5,409,006; 5,443,069; 5,470,350; 5,492,126; 5,573,497; 5,601,526; 5,620,479; 5,630,837; 5,643,179; 5,676,692; 5,840,031. The disclosures of these references are hereby incorporated herein by reference.
HIFU Systems for the treatment of diseased tissue are known. An exemplary HIFU system is the Sonablate® 500 HIFU system available from Focus Surgery, Inc. located at 3940 Pendleton Way, Indianapolis, Ind. 46226. The Sonablate® 500 HIFU system uses a dual-element, confocal ultrasound transducer which is moved by mechanical methods, such as motors, under the control of a controller. Typically one element of the transducer is used for imaging and the other element of the transducer is used for providing HIFU Therapy.
Further details of suitable HIFU systems may be found in U.S. Pat. No. 5,762,066; U.S. Abandoned patent application Ser. No. 07/840,502 filed Feb. 21, 1992, Australian Patent No. 5,732,801; Canadian Patent No. 1,332,441; Canadian Patent No. 2,250,081; and U.S. Pat. No. 6,685,640, the disclosures of which are expressly incorporated by reference herein.
As used herein the term “HIFU Therapy” is defined as the provision of high intensity focused ultrasound to a portion of tissue. It should be understood that the transducer may have multiple foci and that HIFU Therapy is not limited to a single focus transducer, a single transducer type, or a single ultrasound frequency. As used herein the term “HIFU Treatment” is defined as the collection of one or more HIFU Therapies. A HIFU Treatment may be all of the HIFU Therapies administered or to be administered, or it may be a subset of the HIFU Therapies administered or to be administered. As used herein the term “HIFU System” is defined as a system that is at least capable of providing a HIFU Therapy.
The laparoscopic probe of an illustrated embodiment of the present invention is targeted for minimally invasive laparoscopic tissue treatments of the kidney and liver. The probe is light weight, easy to use, and adaptable to the current Sonablate® 500 HIFU system. The laparoscopic probe, with the Sonablate® 500 system, illustratively provides laparoscopic ultrasound imaging, treatment planning, treatment and monitoring in a single probe. The probe fits through a trocar (illustratively an 18 millimeter diameter trocar). A removable, sterile, and disposable probe tip includes a coupling bolus which covers the tip of the probe. The bolus is very thin and illustratively expands to about two or three times its size when water is introduced. This provides a water medium surrounding the probe which is needed for ultrasonic imaging and treatment. Cooling the transducer that provides the imaging and treatment is achieved through a sterile, distilled, degassed passive recirculating water system. The entire probe is ethylene oxide (EO) sterilizable, and the cooling system is gamma-sterilizable.
The laparoscopic probe of the present invention provides an alternative solution to invasive surgery. As a result, recovery time is reduced and hospital visits are considerably shorter. In addition the ablation provided by the laparoscopic probe permits the surgeon to target tissue without stopping the blood supply to the organ. For example, to perform a partial nephrectomy in a conventional manner, the surgeon illustratively shuts off the supply of blood to the kidney and has a limited amount of time to excise the targeted tissue, seal the blood vessels and restart the blood supply to the kidney. If the surgeon takes too long, damage to the kidney and possible organ death may occur. Thus being able to treat large and small volumes of tissue while permitting blood flow to the organ is a significant contribution.
Additional features of the present invention will become apparent to those skilled in the art upon consideration of the following detailed description of illustrative embodiments exemplifying the best mode of carrying out the invention as presently perceived.